中国药品标准2024,Vol.25Issue(6) :624-627.DOI:10.19778/j.chp.2024.06.016

碱式硝酸铋的质量标准研究和探讨

Investigation of the quality standard of bismuth subnitrate

邱娟 李玮玲
中国药品标准2024,Vol.25Issue(6) :624-627.DOI:10.19778/j.chp.2024.06.016

碱式硝酸铋的质量标准研究和探讨

Investigation of the quality standard of bismuth subnitrate

邱娟 1李玮玲1
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作者信息

  • 1. 广州市药品检验所,广州 510160
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摘要

目的:优化完善碱式硝酸铋的质量标准.方法:比较国内外碱式硝酸铋质量标准,结合样品的实验结果,主要对其中文名称、鉴别项、检查项及含量测定进行增修订.结果:按拟定质量标准测定15批样品,含量的结果在71.8%~73.9%之间.建立的碱式硝酸铋质量标准已完成公示.结论:本标准的建立,将为碱式硝酸铋原料药的应用提供质量保障.

Abstract

Objective:To optimize the quality standard of bismuth subnitrate.Methods:In combination with the results of the experiment,the title,identification,test and assay items were added and revised by comparing domestic and international quality standards of bismuth subnitrate.Results:According to the proposed quality standard,the content of 15 batches of samples was 71.8%-73.9%.The drafted standard of bismuth subnitrate has been established.Conclusion:The established standard will provide the quality guarantee for the application of bismuth subnitrate in medicines.

关键词

碱式硝酸铋/质量标准/银盐/铵盐/砷盐/含量测定

Key words

bismuth subnitrate/quality standard/silver/ammonium salts/arsenic/assay

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出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
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